Validation Engineer: Lead IQ/OQ/PQ & GxP Compliance

the-pivot-group-careers; Portage (MI); On-site; USD 72,000 - 111,000; Full time

Job summary

The Pivot Group Network is partnering with Portage-area manufacturers to hire a Validation Engineer. The role focuses on IQ/OQ/PQ, risk assessments, and regulatory compliance within a manufacturing environment.

The successful candidate will lead validation activities for equipment, processes, and software, collaborate with R&D, manufacturing, and QA, and ensure adherence to FDA and ISO standards. Salary ranges from $72,000 to $111,000 plus benefits.

Qualifications

• Bachelor's degree in engineering or related science required.
• 3+ years in validation within regulated manufacturing (medical devices/pharma).
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• Conduct risk assessments and develop mitigation strategies for validation activities.
• Analyze validation data and prepare comprehensive reports summarizing results and conclusions.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Collaborate with cross-functional teams including R&D, manufacturing, and QA.
• Investigate and resolve deviations and non-conformances identified during validation.

Skills

GxP knowledge

Validation lifecycle experience

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering or related science

Tools

Minitab

JMP

PLC/SCADA

Job description

The Pivot Group Network is partnering with Portage-area manufacturers to hire a Validation Engineer. The role focuses on IQ/OQ/PQ, risk assessments, and regulatory compliance within a manufacturing environment.

The successful candidate will lead validation activities for equipment, processes, and software, collaborate with R&D, manufacturing, and QA, and ensure adherence to FDA and ISO standards. Salary ranges from $72,000 to $111,000 plus benefits.